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Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets (ACTFAST 2)

Primary Purpose

Coronary Arteriosclerosis, Diabetes Mellitus, Type 2, Cerebrovascular Accident

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Atorvastatin (Lipitor)
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Arteriosclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • High cholesterol blood levels (LDL-cholesterol above 100 mg/dL up to 220 mg/dL.
  • Triglycerides up to 600 mg/dL.
  • History of coronary artery disease (ex.: heart attack, angina), stroke, diabetes or at high risk of such events.

Exclusion Criteria:

  • Pregnancy or lactation, use of high statin doses (>40mg) at baseline, liver or renal problems
  • Use of other drugs that would interfere with evaluation of efficacy or cause safety problems
  • Uncontrolled hypertension, diabetes or hypothyroidism
  • Recent cardiac event of procedure
  • High baseline CPK levels

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

Proportion of subjects achieving a LDL-C target of < 100 mg/dL (2.6 mmol/L) after 12 weeks.

Secondary Outcome Measures

Percentage of subjects achieving:
LDL-C target <100 mg/dL (<2.6 mmol/L) after 6 weeks of treatment.
Total cholesterol (TC)/HDL-C ratio target (<4.0) after 6 and 12 weeks of treatment.
Either the LDL-C <100mg/dL (<2.6 mmol/L) or TC/HDL-C ratio (<4.0) targets after 6 and 12 weeks of treatment.
Both the LDL-C <100mg/dL (<2.6 mmol/L) and TC/HDL-C ratio (<4.0) targets after 6 and 12 weeks of treatment.
LDL-C <100mg/dL (<2.6 mmol/L) or TC/HDL-C ratio (<4.0) targets after 6 and 12 weeks of treatment by LDL-C strata.
LDL-C target (<100 mg/dL) by primary inclusion diagnosis (CHD, CHD-equivalent, diabetes or 10-year CHD risk-equivalent >20%).
The mean percent change in LDL-C, high density lipoprotein cholesterol (HDL-C),TC/HDL-C ratio, non HDL-C (in subjects with triglycerides [TG] ≥200 mg/dL or 2.3 mmol/L), TC and TG from baseline to 6 and 12 weeks of treatment. Change from baseline in apol

Full Information

First Posted
February 28, 2007
Last Updated
February 17, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00442325
Brief Title
Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets
Acronym
ACTFAST 2
Official Title
ACTFAST (2): Achieve Cholesterol Targets Fast With Atorvastatin Stratified Titration: A Multicenter, Twelve-Week Treatment, Single-Step Titration, Open-Label Study Assessing The Percentage Of Dyslipidemic High-Risk Patients Achieving Low Density Lipoprotein Cholesterol (LDL-C) Target With Atorvastatin Starting Doses Of 10 mg, 20 mg, 40 mg, And 80 mg.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2004 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

Brief Summary
European physicians tend to always use the lowest dose of statins to initiate therapy even in subjects who require large reductions in cholesterol. The study evaluates if selecting the starting dose based on baseline and target LDL-C cholesterol would provide better results (ie proportion of subjects resching target)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Arteriosclerosis, Diabetes Mellitus, Type 2, Cerebrovascular Accident, Dyslipidemia, Peripheral Vascular Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
595 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Atorvastatin (Lipitor)
Primary Outcome Measure Information:
Title
Proportion of subjects achieving a LDL-C target of < 100 mg/dL (2.6 mmol/L) after 12 weeks.
Secondary Outcome Measure Information:
Title
Percentage of subjects achieving:
Title
LDL-C target <100 mg/dL (<2.6 mmol/L) after 6 weeks of treatment.
Title
Total cholesterol (TC)/HDL-C ratio target (<4.0) after 6 and 12 weeks of treatment.
Title
Either the LDL-C <100mg/dL (<2.6 mmol/L) or TC/HDL-C ratio (<4.0) targets after 6 and 12 weeks of treatment.
Title
Both the LDL-C <100mg/dL (<2.6 mmol/L) and TC/HDL-C ratio (<4.0) targets after 6 and 12 weeks of treatment.
Title
LDL-C <100mg/dL (<2.6 mmol/L) or TC/HDL-C ratio (<4.0) targets after 6 and 12 weeks of treatment by LDL-C strata.
Title
LDL-C target (<100 mg/dL) by primary inclusion diagnosis (CHD, CHD-equivalent, diabetes or 10-year CHD risk-equivalent >20%).
Title
The mean percent change in LDL-C, high density lipoprotein cholesterol (HDL-C),TC/HDL-C ratio, non HDL-C (in subjects with triglycerides [TG] ≥200 mg/dL or 2.3 mmol/L), TC and TG from baseline to 6 and 12 weeks of treatment. Change from baseline in apol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: High cholesterol blood levels (LDL-cholesterol above 100 mg/dL up to 220 mg/dL. Triglycerides up to 600 mg/dL. History of coronary artery disease (ex.: heart attack, angina), stroke, diabetes or at high risk of such events. Exclusion Criteria: Pregnancy or lactation, use of high statin doses (>40mg) at baseline, liver or renal problems Use of other drugs that would interfere with evaluation of efficacy or cause safety problems Uncontrolled hypertension, diabetes or hypothyroidism Recent cardiac event of procedure High baseline CPK levels
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Ioannina
Country
Greece
Facility Name
Pfizer Investigational Site
City
Kallithea, Athens
Country
Greece
Facility Name
Pfizer Investigational Site
City
Pireaus
Country
Greece
Facility Name
Pfizer Investigational Site
City
Thessaloniki
Country
Greece
Facility Name
Pfizer Investigational Site
City
Budapest
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Gyula
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Kecskemet
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Nyíregyháza
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Szekszárd
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Tullamore
State/Province
CO. Offlay
Country
Ireland
Facility Name
Pfizer Investigational Site
City
Tallaght
State/Province
Dublin
Country
Ireland
Facility Name
Pfizer Investigational Site
City
Gorey
State/Province
Wexford
Country
Ireland
Facility Name
Pfizer Investigational Site
City
Cork
Country
Ireland
Facility Name
Pfizer Investigational Site
City
Dublin 8
Country
Ireland
Facility Name
Pfizer Investigational Site
City
Dublin
Country
Ireland
Facility Name
Pfizer Investigational Site
City
Galway
Country
Ireland
Facility Name
Pfizer Investigational Site
City
Czestochowa
Country
Poland
Facility Name
Pfizer Investigational Site
City
Poznan
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warszawa
Country
Poland
Facility Name
Pfizer Investigational Site
City
Wroclaw
Country
Poland
Facility Name
Pfizer Investigational Site
City
Zabrze
Country
Poland
Facility Name
Pfizer Investigational Site
City
Aveiro
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Lisboa
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Porto
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Vila Franca de Xira
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Bratislava
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Kosice
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Bern
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Genève
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Mendrisio
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Zürich
Country
Switzerland
Facility Name
Pfizer Investigational Site

12. IPD Sharing Statement

Citations:
PubMed Identifier
17626713
Citation
Farsang C, Athyros V, Gaw A; ACTFAST-2 investigators and Steering Committee members. A multicentre, open study to assess the effect of individualizing starting doses of atorvastatin according to baseline LDL-C levels on achieving cholesterol targets: the Achieve Cholesterol Targets Fast with Atorvastatin Stratified Titration (ACTFAST-2) study. Curr Med Res Opin. 2007 Aug;23(8):1945-56. doi: 10.1185/030079907X223242.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2581095&StudyName=Benefits+Of+Using+Various+Starting+Doses+Of+Atorvastatin+On+Achievement+Of+Cholesterol+Targets+%28ACTFAST+2%29
Description
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Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets

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